BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3870953 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18823
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS CONFIRMED THAT THE PATIENT DIED ON (B)(6) 2014. LOT NUMBER, EXPIRATION DATE, AND OTHER NUMBER ARE NOT APPLICABLE FOR A HARDWARE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE SAMPLE ANALYSIS WAS NOT PERFORMED BECAUSE THE COMPLAINT WAS ENTERED INTO PMDA AFTER THE DEVICE WAS RECEIVED AND ROUTED FOR SERVICING. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED RELATED TO THE REPORTED PROBLEM. AS A RESULT, THE DIRECT CAUSE OF THE REPORTED PROBLEM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PERITONEAL DIALYSIS (PD) THERAPY PATIENT WHO PASSED AWAY ON AN UNREPORTED DATE. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF THERAPY WAS ONGOING AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350188 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death DIANEAL PD4 2.5% AND 4.25% AMBUFLEX